MedTrace Logo

Safety and Effectiveness of OBG vs.a Bandage Contact Lens for Large Corneal Epithelial Defects in Patients Post-PRK.

NCT03163641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-12-17

No results posted yet for this study

Summary

This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area.

Conditions

  • Corneal Epithelial Wound

Interventions

DEVICE

Acuvue Oasys

Bandage Contact Lens

DEVICE

Ocular Bandage Gel

0.75% crosslinked HA

Sponsors & Collaborators

  • Eyegate Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara Wirostko, M.D. · Eyegate Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-05
Primary Completion
2018-10-31
Completion
2018-11-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163641 on ClinicalTrials.gov